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February 5, 2026
Approximately 5 minutes
Completion Requirements for Clinical Investigations of Medical Devices in Denmark
Completion Requirements for Clinical Investigations of Medical Devices in Denmark
1. Notification of Completion
The sponsor must notify the Danish Medicines Agency of the completion of the clinical investigation no later than 15 days after completion, using the designated form for notification. Source: Danish Medicines Agency Completion of Investigation Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/completion-of-investigation/
2. Final Report Submission
The clinical investigation report must be submitted no later than 12 months after the investigation ends. It must include a critical assessment of all collected data. Source: Danish Medicines Agency Completion of Investigation Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/completion-of-investigation/
3. Early Termination or Temporary Halt
In case of early termination or temporary halt, notify the Agency within 15 calendar days with justification. The final report must be submitted as soon as possible and no later than 3 months after early termination. Source: Danish Medicines Agency Completion of Investigation Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/completion-of-investigation/
4. Content Requirements
The final report must include a critical assessment of all data. Use Annex D of DS/EN ISO 14155:2020 as a template. Minimum elements are in Annex XV, Chapter III, paragraph 7 of the MDR. Refer to MDCG 2021-6 for Q&A and European Commission guidance for summary structure. Source: Danish Medicines Agency Completion of Investigation Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/completion-of-investigation/ MDCG 2021-6: https://health.ec.europa.eu/system/files/2021-07/mdcg_2021-6_rev1_en_0.pdf
5. Public Availability
For investigations authorised under Article 62 after 26 May 2021, the report must be publicly available in EUDAMED within 12 months (Article 77(7) MDR). Until EUDAMED is ready, reports are published on the European Commission website via Circabc. The Agency forwards reports to the Commission. Guidance: MDCG 2024-15. Source: Danish Medicines Agency Completion of Investigation Page https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations/completion-of-investigation/ MDCG 2024-15: https://health.ec.europa.eu/system/files/2024-07/mdcg_2024-15_en_0.pdf
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